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Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and HIPAA privacy and security. Ms. Kraus is co-chair of the firm’s Health Care Industry practice group.

  • Advising AstraZeneca on its global digital health partnership with BrightInsight for the development of digital health products and services (including Software as a Medical Device products).
  • Assisted a major pharmaceutical manufacturer in conducting an internal audit of its price reporting function and determining the necessity for submitting restated price reports.
  • Assisted a pharmaceutical company in obtaining Medicare Part D coverage for its previously excluded product.
  • Assisted several pharmaceutical manufacturers in modifying their price reporting functions to comply with requirements imposed by the Deficit Reduction Act and the Affordable Care Act.
  • Assisted numerous pharmaceutical manufacturers to ensure that their research activities conform to HIPAA and HITECH privacy requirements (for example, by conducting internal audits and by preparing investigator disclosure documents, contract research organization (CRO) agreements, clinical trial agreements, service provider agreements, informed consents and authorizations).
  • Assisted several device manufacturers to assess their status as business associates under HIPAA and HITECH and to develop appropriate compliance plans, policies and procedures.

Previous Experience

  • U.S. Department of Health and Human Services, Deputy General Counsel (1993-2001)
  • Legal 500 US, Media, Technology & Telecoms - Technology: Data Protection & Privacy (2013)
  • Washington DC Super Lawyer, Health Care (2013-2015)
  • LMG Life Sciences, “Life Science Star” (2012-2013)